Volume 51, No. 12/2013(December)
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Original
Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer’s disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study
Izuru Miyoshi, Yoko Fujimoto, Masahito Yamada, Sadahiro Abe, Qinying Zhao, Carol Cronenberger, Kanae Togo, Taro Ishibashi, Martin M. Bednar, James W. Kupiec and Brendon Binneman
Price
42.00 $
Page No. 911
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (911-923)
Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer’s disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study
Izuru Miyoshi1*, Yoko Fujimoto1, Masahito Yamada2, Sadahiro Abe1, Qinying Zhao3, Carol Cronenberger3, Kanae Togo1, Taro Ishibashi1, Martin M. Bednar3, James W. Kupiec3 and Brendon Binneman3
1Pfizer Japan Inc., Tokyo, 2Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan, and 3Pfizer Inc., Groton, CT, and Cambridge, MA, USA
Objective: PF-04360365 is a humanized IgG2Δa anti-amyloid β (Aβ) antibody designed to improve outcome in Alzheimer’s disease (AD). Single doses of 0.1 – 10 mg/kg were safe and well tolerated in Western (mostly Caucasian) subjects with mild-to-moderate AD. This Phase 1, multicenter, randomized, double-blind, dose-escalation study was the first to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of PF-04360365 in Japanese subjects. Materials and methods: 30 subjects with mild-to-moderate AD were enrolled. In each cohort, 3 subjects received PF-04360365 (0.1, 0.5, 1, 5, or 10 mg/kg) and 1 subject received placebo as a single 2-hour intravenous infusion. Subjects were monitored as inpatients for 24 hours and then as outpatients for 1 year. Results: All subjects completed the study. There were no serious or National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥ 3 adverse events, hypersensitivity reactions, or antidrug antibodies. No clinical or MRI evidence of brain microhemorrhage, cerebral edema, or encephalitis was observed. PF-04360365 plasma concentrations increased with dose, and pharmacokinetics were consistent with a small steady-state volume of distribution, slow clearance, and long elimination half-life. Cerebrospinal fluid (CSF):plasma ratios were < 0.5%. Plasma Aβ species showed dose-dependent increases in Cmax and AUC∞, but CSF biomarkers did not differ clearly between treatment arms. Conclusions: PF-04360365 was safe and well tolerated in Japanese subjects. Pharmacokinetics and plasma pharmacodynamic responses in Japanese subjects were comparable to those in Western subjects.
*No longer affiliated with Pfizer.Correspondence to:
Yoko Fujimoto, MD, PhD
Pfizer Japan Inc.
Shinjuku Bunka Quint Bldg.
3-22-7, Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan
Email: [email protected]
Original
Prospective randomized, double-blind, placebo controlled trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair
Jingwen Wang, Gang Ji, Zhifu Yang, Miaomiao Xi, Yin Wu, Peixi Zhao, Lei Wang, Wenhan Yu and Aidong Wen
Price
42.00 $
Page No. 924
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (924-931)
Prospective randomized, double-blind, placebo controlled trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair
Jingwen Wang1*, Gang Ji2, Zhifu Yang1*, Miaomiao Xi1, Yin Wu1, Peixi Zhao1, Lei Wang1, Wenhan Yu1 and Aidong Wen1
1Department of Pharmacy, and 2Department of Gastroenterological Surgery, Xijing Hospital, Fourth Military Medical University, Xi’an, Shanxi, China
Objective: Infection is one of possible complications after prosthetic material hernia repair surgery. Antibiotic prophylaxis is applied routinely in China, but its effect is still controversial. The present study aims to offer direct clinical evidence on prevention of infection after tension-free inguinal hernia repair. Methods: A total of 1,200 cases with primary inguinal hernia treated in 6 hospitals in Shaanxi Province were enrolled in this study. They were randomly divided into three groups (n = 400 per group): placebo control group, Cefazolin group and Levofloxacin group after tensionfree inguinal hernia repair using polypropylene mesh. Hernia type, age, gender, weight and complications were recorded. The surgical-site infection was diagnosed according to APIC, CDC criteria (http://www.apic. org). Infections were evaluated every other day in the first week, and then at 14 days, 21 days and 30 days following surgery. Results: Two cases from the placebo group, 3 from the Cefazolin group and 3 from the Levofloxacin group failed to follow-up. Six patients (2 non-following the protocol, 2 severe depression, and 2 laparoscopic surgery) from the placebo group, 14 (8 nonreceiving trial medication, 5 laparoscopic surgery, and 1 failure to tolerance) from the Cefazolin group, and 12 (2 combination of antibiotic usage, 5 laparoscopic surgery and 5 failure to tolerance) from the Levofloxacin group were excluded. The data of the 1,160 cases were statistically analyzed in the incidence rates of surgical-site infection and complications after inguinal hernia repair. Surgical-site infection including wound infection, cellulitis or mesh-related infection was found in 20 cases (5.1%) of the control group, 15 (3.92%) of the Cefazolin group and 17 (4.42%) of the Levofloxacin group, and the difference among the three groups was not statistically significant (χ2 = 0.438, p = 0.803). There was also no significant difference in post-surgery complications including seroma (p = 0.6366), urinary retention (p = 0.8136), fat liquefaction (p = 0.8061), pulmonary infection (p = 0.1911), and urinary tract infection (p = 0.8144) among the three groups. Conclusions: Prophylactic use of Cefazolin or Levofloxacin did not significantly decrease the risk of wound infection in these patients undergoing inguinal hernia repair. The present results do not support the administration of antibiotic prophylaxis for tension-free inguinal hernia repair.
*The authors contributed equally to this workCorrespondence to:
Prof. Aidong D. Wen
Department of Pharmacy, Xijing Hospital
Fourth Military Medical University
No.15 Changle West Road, Xi’an, Shanxi 710032, China
Email: [email protected]
Original
Oseltamivir effectiveness in seasonal influenza patients taking symptomatic therapy: retrospective analysis of RCT data
Stephen Toovey, Regina Dutkowski, Paul Smith and James R. Smith
Price
42.00 $
Page No. 932
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (932-941)
Oseltamivir effectiveness in seasonal influenza patients taking symptomatic therapy: retrospective analysis of RCT data
Stephen Toovey1, Regina Dutkowski2, Paul Smith3 and James R. Smith1
1F. Hoffmann-La Roche Ltd, Basel, Switzerland, 2Hoffmann-La Roche, Inc., Nutley, NJ, USA, and 3Statistics for Research Ltd, Basel, Switzerland
Aims: The effectiveness of oseltamivir to improve seasonal influenza symptoms in clinical practice was analyzed using pooled data from patients who were also taking analgesics and other over-the-counter (OTC) medications. Methods: Data were pooled from 1,709 patients aged 13 – 64 years with confirmed seasonal influenza who enrolled in six randomized, placebo-controlled trials of oseltamivir (75 mg b.i.d. for 5 days) and took OTC analgesics (+/– other medications). Rates of improvement of seven symptoms, two functional measures (sleep quality and ability to undertake usual activities) and fever (body temperature) were calculated between Days 1 and 6 of illness. Time to reach defined tolerability thresholds was compared using Kaplan-Meier analysis. Two subgroup analyses were performed in patients taking cough and cold remedies (n = 635) and antibiotics (n = 175) in addition to analgesics. Results: Six symptoms and both functional measures improved faster with oseltamivir than placebo, including nasal congestion (difference in rate, 19.3%), cough (34.1%), sleep quality (13.7%) and ability to perform usual activities (12.0%). Results in the Analgesics + cough/cold subgroup analysis were similar. In the Analgesics + antibiotics subgroup, three symptoms and both functional measures improved faster with oseltamivir. In all three analyses, median time to reach tolerability thresholds for all measures was faster in oseltamivir patients than placebo patients. Conclusions: Oseltamivir treatment of patients with seasonal influenza already receiving OTC medications produced a faster reduction in severity of most symptoms and a quicker return to ability to perform normal activities compared with patients who took OTC medications and placebo.Correspondence to:
Stephen Toovey
F. Hoffmann-La Roche Ltd
PBMT Bldg 74/3O Z01.05, 4070, Basel, Switzerland
Email: [email protected]
Original
A pharmacokinetic assessment of an alternate titration strategy for fentanyl pectin nasal spray
Michael Perelman and Alastair Knight
Price
42.00 $
Page No. 942
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (942-947)
A pharmacokinetic assessment of an alternate titration strategy for fentanyl pectin nasal spray
Michael Perelman1 and Alastair Knight2
1Archimedes Development Ltd., Nottingham, and 2Evicom Ltd., Teddington, UK
Objective: Fentanyl pectin nasal spray (FPNS) is approved for management of breakthrough pain in cancer. It is available in 100 and 400 μg strength products which allow for doses of 100 – 800 μg (1 or 2 sprays). Existing titration strategies require a transition from the 100 μg product to the 400 μg product when increasing the dose from 200 to 400 μg. This study assessed the pharmacokinetic (PK) profile of FPNS administered as 4 sprays of 100 μg as an alternate titration strategy. Methods: In this 3-way, crossover study, healthy subjects aged 18 – 65 years were randomized to receive each of 3 dosages of FPNS (4 × 100 μg, 2 × 100 μg, and 1 × 400 μg). PK samples were collected over 24 hours. Results: Of 22 subjects randomized, 20 were included in the PK analysis. Administration of both 400 μg regimens (4 × 100 μg and 1 × 400 μg) provided greater systemic fentanyl exposure compared with the 200 μg dose (Cmax: 1,748 and 1,485 pg/ml vs. 1,051 pg/ml; AUC0–1h: 1,012 and 944 pg×h/ml vs. 665 pg×h/ml; and tmax: 0.25 hours and 0.50 hours vs. 0.25 hours); fentanyl exposure after 4 × 100 μg and 1 × 400 μg regimens was similar. Adverse events (AEs) were all mild or moderate in intensity; most common AEs were nausea (50%) and headache (23%). AE frequency was similar across treatments without reports of nasal effects. Conclusions: Given that systemic fentanyl exposure from FPNS administered as 4 × 100 μg is similar to that from FPNS as 1 × 400 μg, the 4 × 100 μg regimen provides an alternate titration strategy for patients needing more than 200 μg. This alternate strategy will facilitate a patient’s ability to achieve an optimized FPNS regimen and reduce opioid wastage.Correspondence to:
Michael Perelman
Archimedes Development Ltd.
Albert Einstein Centre
Nottingham Science and Technology Park
University Boulevard, Nottingham NG7 2TN, UK
Email: [email protected]
Original
High-quality triplicate electrocardiogram monitoring in a first-in-man study: potential for early detection of drug-induced QT prolongation
Yan-Ling He, Yiming Zhang, Jing-He Yan, Wei Zhou, Steven Komjathy and Ann Taylor
Price
42.00 $
Page No. 948
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (948-957)
High-quality triplicate electrocardiogram monitoring in a first-in-man study: potential for early detection of drug-induced QT prolongation
Yan-Ling He1, Yiming Zhang2, Jing-He Yan2, Wei Zhou2, Steven Komjathy3 and Ann Taylor1
1Novartis Institutes for BioMedical Research, Cambridge, MA, 2Novartis, East Hanover, NJ, and 3Charles River Clinical Services Northwest Inc., Tacoma, WA, USA
Background: QT interval prolongation is associated with an increased risk of potentially fatal ventricular tachycardias, including torsade de pointes. Regulatory guidance recommends the “thorough QT/QTc” (TQT) study as the gold standard for assessing the propensity of novel nonantiarrhythmic drugs to delay cardiac repolarization. An opportunity exists, however, to use high-quality electrocardiogram (ECG) data from first-in-man trials as an exploratory and complementary approach to gain early insight into potential risk of QT prolongation. Methods: We collected high-quality, triplicate, 12-lead ECG data during a first-in-man trial of a drug developed for the treatment of Type 2 diabetes that had shown in vitro hERG inhibition and potential to prolong QT intervals in an animal model. Results: QTc prolongation was observed at the highest dose, leading to a maximum QTcF prolongation > 19 ms at 6 hours after the 14th daily dose. QTcF increases from time-matched baseline relative to placebo were positively correlated with peak plasma concentrations. Conclusions: Clinically relevant QT interval prolongations can be detected during first-in-man studies using high-quality ECG monitoring. Such data may facilitate early decision making on whether to terminate the development of a compound and invest resources in more promising molecules; and it may enable more efficient TQT study design or preclude the need for future TQT studies.Correspondence to:
Yan-Ling He, PhD, DMSc
Translational Medicine
Novartis Institutes for BioMedical Research
220 Massachusetts Avenue, Building 605
Cambridge, MA, 02139-3584, USA
Email: [email protected]
CaseReport
Montelukast sodium-induced hematuria: a case report and literature review of 19 cases in mainland China
Jian-Xiang Xie, Ji-Fu Wei and Ling Meng
Price
42.00 $
Page No. 958
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (958-962)
Montelukast sodium-induced hematuria: a case report and literature review of 19 cases in mainland China
Jian-Xiang Xie, Ji-Fu Wei and Ling Meng
Research Division of Clinical Pharmacology, The First Affiliate Hospital of Nanjing Medical University, Nanjing, Jiangsu, The People’s Republic of China
We report a rare case of montelukast sodium-induced hematuria in a 58-year-old female patient with allergic rhinitis. Renal function returned to normal after drug withdrawal. We reviewed 19 case reports of adverse reactions associated with montelukast sodium in mainland China and found that (1) 37% of patients were pediatric patients, (2) psychiatric disorders, rashes and uropoietic organs symptom were common, (3) uropoietic organ symptoms reported in mainland China were very rare abroad. The clinician in China should be vigilant about the adverse reaction of montelukast sodium and further studies are needed to explore the pathogenesis of montelukast-induced uropoietic organ symptoms.Correspondence to:
Ling Meng
Research Division of Clinical Pharmacology
The First Affiliate Hospital of Nanjing Medical University
Nanjing, Jiangsu 210029, China
Email: [email protected] and [email protected]
Original
ACE inhibitors and angiotensin receptor blockers could promote the onset of endometrial polyps in hypertensive women
Ugo Indraccolo, Maria Matteo, Pantaleo Greco, Fabrizio Barbieri and Fiorenzo Mignini
Price
42.00 $
Page No. 963
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (963-968)
ACE inhibitors and angiotensin receptor blockers could promote the onset of endometrial polyps in hypertensive women
Ugo Indraccolo1, Maria Matteo2, Pantaleo Greco2, Fabrizio Barbieri3 and Fiorenzo Mignini4
1Complex Operative Unit of Gynecology and Obstetrics of Civitanova Marche, Area Vasta 3, Marche, 2Department of Clinical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, 3Complex Operative Unit of Gynecology and Obstetrics of Bussolengo, ULSS 22, Veneto, and 4School of Pharmacy, University of Camerino, Italy
Objective: To investigate whether anti-hypertensive therapy is a risk factor for the onset of endometrial polyps in hypertensive women. Methods: A sample of 305 hypertensive patients was analyzed. By applying multivariable logistic regression analysis, the odds of developing endometrial polyps relative to the known risk factors for endometrial polyps and to the class of anti-hypertensive drugs were calculated. Results: The variables reaching significance after multivariable logistic regression analysis included the following: hypertension not-in-therapy (odds ratio 2.544; 95% confidence intervals 1.249 – 5.182; p = 0.010); ACE inhibitor therapy (odds ratio 2.400; 95% confidence intervals 1.248 – 4.614; p = 0.009); angiotensin receptor blockers (odds ratio 2.091; 95% confidence intervals 1.044 – 4.187; p = 0.037); and fasting glucose level (odds ratio 1.018; 95% confidence intervals 1.007 – 1.030; p = 0.001). Conclusions: Although the results should be interpreted carefully, it appears that ACE inhibitors and, to a lesser extent, angiotensin receptor blockers may promote the onset of endometrial polyps in hypertensive patients.Correspondence to:
Dr. Ugo Indraccolo, MD, PhD
Via Montagnano 16, 62032 Camerino (MC), Italy
Email: [email protected]
Original
Adherence in tamoxifen therapy after conversion to a rebate pharmaceutical in breast cancer patients in Germany
Karel Kostev, Uwe May, Daniela Hog, Janine Eisel, Tim Kremmers, Marjan Kosteic, Lilia Waehlert and Peyman Hadji
Price
42.00 $
Page No. 969
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (969-975)
Adherence in tamoxifen therapy after conversion to a rebate pharmaceutical in breast cancer patients in Germany
Karel Kostev1*, Uwe May2*, Daniela Hog2, Janine Eisel2, Tim Kremmers2, Marjan Kosteic2, Lilia Waehlert2 and Peyman Hadji3
1IMS Health, Frankfurt, 2Hochschule Fresenius, FB Wirtschaft und Medien, FG Gesundheitsökonomie, Idstein, and 3Department of Gynecology, Endocrinology and Oncology, Phillips-University of Marburg, Germany
Background: The aim of this study was to investigate the risk of therapy discontinuation in breast cancer patients treated with tamoxifen with and without conversion to a rebate pharmaceutical (tamoxifen) and to analyze the negative consequences of rebate contracts on the compliance of breast cancer patients among gynecologist and general practitioner practices in Germany. Methods: This retrospective analysis was performed using the IMS Disease Analyzer® database. Women with a diagnosis of breast cancer and first time prescription of tamoxifen in the time from January 2008 until December 2011 were selected. Main outcome measure was the incident the hormone treatment discontinuation rates within 3 years after index date. Treatment discontinuation of tamoxifen was defined as 90 days without this or alternative hormonal therapy (aromatase inhibitors) during that time. Results: In total, 3,620 patients were included in the persistence analysis. 1,712 (47.3%) patients were converted to a rebate product. Within 3 years of follow-up, the discontinuation rates increased to 51.5% for switched patients and 46.3% for patients without switch (p < 0.01). Hazard ratios for 3-year risk of tamoxifen therapy discontinuation were adjusted for age, sex, gynecologist care, patient and physician’s residency, baseline co-morbidities (osteoporosis, diabetes, depression and thrombosis, side effects). These analyses comprised a significantly increased risk for treatment discontinuation for patients who were switched to a rebate pharmaceutical compared to patients without conversion to a rebate pharmaceutical (HR: 1.27, CI: 1.05 – 1.53, p = 0.014). Conclusions: This analysis underlines an association between the initiation of rebate contracts and a negative impact on the compliance of breast cancer patients on an adjuvant hormonal treatment The impact of rebate contracts on the health of patients and the health care costs should be evaluated in further therapeutic fields through additional research projects.
*both authors contributed equally to the manuscriptCorrespondence to:
Dr. Karel Kostev
Senior Research Advisor
IMS HEALTH – Epidemiology
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]
Original
No clinically relevant interaction between sugammadex and aspirin on platelet aggregation and coagulation parameters
Pieter-Jan de Kam, Rachid El Galta, Annelieke C. Kruithof, Hein Fennema, Marie-José van Lierop, Katsuhiro Mihara, Jacobus Burggraaf, Matthijs Moerland, Pierre Peeters and Matthew D. Troyer
Price
42.00 $
Page No. 976
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (976-985)
No clinically relevant interaction between sugammadex and aspirin on platelet aggregation and coagulation parameters
Pieter-Jan de Kam1, Rachid El Galta2, Annelieke C. Kruithof3, Hein Fennema2, Marie-José van Lierop2, Katsuhiro Mihara2, Jacobus Burggraaf3, Matthijs Moerland3, Pierre Peeters2* and Matthew D. Troyer1
1Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA, 2MSD, Oss, and 3CHDR (Centre for Human Drug Research), Leiden, The Netherlands
Objectives: This study evaluated interaction potential between sugammadex and aspirin on platelet aggregation. Methods: This was a randomized, double-blind, placebo-controlled, four-period crossover study in 26 healthy adult males. Treatments were i.v. placebo, i.v. sugammadex 4 mg/kg, and i.v. placebo/sugammadex with oncedaily oral aspirin 75 mg. Primary objective was to assess interaction between sugammadex and aspirin on platelet aggregation using collagen-induced whole-blood aggregometry. Effects on activated partial thromboplastin time (APTT) and cutaneous bleeding time were also evaluated. Platelet aggregation and APTT were evaluated by geometric mean ratios, using area-under-effect curves 3 – 30 minutes after sugammadex/placebo dosing. Bleeding time ratio was evaluated at 5 minutes post-dosing. Non-inferiority margins were pre-specified via literature review. Type I error was controlled using a hierarchical strategy. Results: Ratio for platelet aggregation for aspirin with sugammadex vs. aspirin alone was 1.01, with lower limit of two-sided 90% CI of 0.91(above non-inferiority margin of 0.75). Ratio for statistical interaction between sugammadex and aspirin on APTT was 1.01, with upper 90% CI of 1.04 (below non-inferiority margin of 1.50), and for sugammadex vs. placebo alone was 1.06, with an upper 90% CI of 1.07 (below non-inferiority margin of 1.50). Ratio for bleeding time for aspirin with sugammadex vs. aspirin plus placebo was 1.20, with upper 90% CI of 1.45 (below non-inferiority margin of 1.50). Sugammadex was generally well tolerated. Conclusion: There was no clinically relevant reduction in platelet aggregation with addition of sugammadex 4 mg/kg to aspirin. Pre-determined non-inferiority margins were not exceeded for bleeding time and APTT.Correspondence to:
Dr. Pieter-Jan de Kam, PhD
Clinical Pharmacology, Merck Sharp & Dohme Corp.
126 East Lincoln Avenue, Room RY34A-5039
Rahway, NJ 07065-0900, USA
Email: [email protected]
Short Report
Lower metabolic clearance of tizanidine in Japanese subjects
Kenji Momo, Masato Homma and Yukinao Kohda
Price
42.00 $
Page No. 986
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (986-988)
Lower metabolic clearance of tizanidine in Japanese subjects
Kenji Momo, Masato Homma and Yukinao Kohda
Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan
Our aim was to determine whether metabolic clearance, renal clearance, or both elimination pathways contribute to ethnic differences in tizanidine clearance, which is ~ 2-fold higher in Caucasians than in Asians. The pharmacokinetic parameters of tizanidine in 9 healthy male Japanese subjects were compared with those of Caucasians in previous studies. Metabolic clearance of tizanidine was lower in Japanese than in Caucasian subjects (5.9 vs. 8.1 – 10.9 l/h/kg), although renal clearances were similar (0.040 vs. 0.047 – 0.055 l/h/kg). The results suggest that ethnic differences in tizanidine clearance are due to differences in metabolic clearance.Correspondence to:
Dr. Masato Homma
Department of Pharmaceutical Sciences
Faculty of Medicine, University of Tsukuba
Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
Email: [email protected]
Letter to the Editor
The role of sevelamer carbonate in increasing serum bicarbonate in hyperphosphatemic predialysis patients who have metabolic acidosis
Sarah Bezzaoucha, Vincent Pichette, Jean-Philippe Lafrance, Robert Bell, Louis-Philippe Laurin and Michel Vallée
Page No. 989
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 – Letter to the editor
The role of sevelamer carbonate in increasing serum bicarbonate in hyperphosphatemic predialysis patients who have metabolic acidosis
Sarah Bezzaoucha, Vincent Pichette, Jean-Philippe Lafrance, Robert Bell, Louis-Philippe Laurin and Michel Vallée
Service de Néphrologie, Hôpital Maisonneuve-Rosemont, Département de Médecine, Université de Montréal, Quebec, Canada
Correspondence to:
Michel Vallée, MD, PhD
Nephrology, Department of Medicine
Hôpital Maisonneuve-Rosemont
5415 Boulevard de l’Assomption
Montréal, Québec, H1T 2M4 Canada
Email: [email protected]
Letter to the Editor
Impact of CYP3A and ABCB1 polymorphisms on the pharmacokinetics and pharmacodynamics of fentanyl
Victoria C. Ziesenitz and John N. van den Anker
Page No. 991
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 – Letter to the editor
Impact of CYP3A and ABCB1 polymorphisms on the pharmacokinetics and pharmacodynamics of fentanyl
Victoria C. Ziesenitz1,2 and John N. van den Anker1
1Division of Pediatric Clinical Pharmacology, Children’s National Medical Center, Washington DC, USA and 2Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
Correspondence to:
Dr. med. Victoria Ziesenitz
Heidelberg University Hospital
Department of Clinical Pharmacology and Pharmacoepidemiology
Im Neuenheimer Feld 410, 69120 Heidelberg, Germany
Email: [email protected]
Letter to the Editor
Aminoglycosides and ototoxicity in neonates: Is there a relation with serum concentrations?
Samira Samiee-Zafarghandy and Johannes N. van den Anker
Page No. 993
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 – Letter to the editor
Aminoglycosides and ototoxicity in neonates: Is there a relation with serum concentrations?
Samira Samiee-Zafarghandy1 and Johannes N. van den Anker1,2
1Division of Pediatric Clinical Pharmacology, Children’s National Medical Center, and 2Departments of Pediatrics, Pharmacology, Physiology and Integrative Systems Biology, George Washington University School of Medicine and Health Sciences, Washington, D.C., USA
Correspondence to:
Samira Samiee, MD
Division of Pediatric Clinical Pharmacology
Children’s National Medical Center
111 Michigan Ave. NW. Washington, DC, 20010, USA
Email: [email protected]
